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About the Role
The Quality Systems Training Specialist is responsible for developing and maintaining a compliant GMP training program by partnering with cross-functional teams to ensure training strategies, qualification requirements, and learning activities meet global regulatory and quality standards.
Responsibilities
- Collaborate with cross-functional teams to establish and maintain training strategies that align with applicable regulatory requirements.
- Ensure compliance with training requirements defined in 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q8, ICH Q9, ICH Q10, ISO 9001, ISO 13485 and other international guidelines.
- Independently administer and maintain the electronic Learning Management System (LMS), including training assignments, curricula, job codes, user access, qualification programs, periodic reviews, and training record management.
- Conduct impact assessments for new and revised procedures to determine appropriate training requirements, delivery methods, and qualification activities.
- Monitor training compliance, identify overdue or at-risk training activities, investigate training-related issues, and work directly with functional leadership to drive timely resolution.
- Provide guidance to managers and associates regarding training requirements, qualification expectations, and compliance obligations.
Requirements
- 3+ years of relevant experience in creating/facilitating training programs.
- Biotech, pharma, or medical device document control experience preferred.
- Experience with establishing and maintaining training programs in electronic document management systems.
- MasterControl experience preferred.
- 10% travel to Fargo, ND and/or Coralville, IA required.
Skills
- Strong foundational knowledge in competency based/application based training.
Location
- Remote
Work Type
- Remote
Experience Level
- 3+ years
Education Level
- Bachelor’s Degree required; life science related field, preferred.
Salary/Compensations
- $70,000 - $90,000
Benefits
- Paid time off
- Medical/dental/vision insurance
- 401(k)
About the Company
- At Integrated DNA Technologies (IDT), one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
- Our team at Integrated DNA Technologies (IDT), is united by a commitment to collaboration and scientific excellence, building on a strong foundation of innovation, expertise, and reliability.
- Guided by our vision to help researchers rapidly move from the lab to life-changing advances, we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer, infectious disease, rare genetic disorders, and more.
- At IDT, you’ll be part of a culture rooted in continuous learning and improvement—where your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier, brighter future for all.
- Learn about the Danaher Business System which makes everything possible.
- For more information, visit www.danaher.com.
Equal Opportunity
- Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
- We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities.